Kornimate/medical-research-clean huggingface dataset:
efficacy of calcitriol in recent onset type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: reduction in vitamin d levels has been reported in subjects with recent onset type 1 diabetes. several studies suggest that vitamin d supplementation in early childhood decreases the risk of developing type 1 diabetes, therefore vitamin d deficiency might play a role in the disease pathogenesis. we investigated whether the supplementation of the active form of vitamin d (calcitriol) in subjects with recent-onset type 1 diabetes can protect residual beta cell function evaluated by c peptide and improve glycaemic control as evaluated by hba1c and insulin requirement. thirty-four subjects (age range 11-35 years, median 18 years) with recent-onset type 1 diabetes (\ 0.25 nmol/l were randomized in a double-blind trial to calcitriol (the active form of vitamin d, 1.25-dihydroxyvitamin d3 \[1,25-(oh)2d3\] ) at the dose of 0.25 ug/day or placebo, and followed up for 2 years.


Eligibility criteria:
inclusion criteria: 1. diagnosis of type 1 diabetes according to the american diabetes association (ada) guidelines; 2. age at presentation between 11 and 35 years; 3. duration of clinical disease (since the beginning of insulin therapy) \<12 weeks; 4. baseline c-peptide \>0.25 nmol/l; 5. no medical contra-indications or any other major chronic disease; 6. willingness and capability to participate in a regular follow-up. exclusion criteria: 1. cardiovascular disease; 2. renal disease; 3. liver disease; 4. neurological disorders; 5. allergic diathesis; 6. hyperparathyroidism; 7. neoplasia.
shockwaves therapy and botulinum toxin for the treatment of spasticity in patients with cerebral palsy. a cross over rct

Conditions: Spasticity; Cerebral Palsy

Summary: spasticity is a motor disorder that can affect the lower limbs in up to 75% patients with cerebral palsy, having a significantly effect on their mobility and quality of life. there is much controversy about what is the most appropriate treatment of spasticity the objective of the present study is to evaluate the effects of radial extracorporeal shock wave therapy (reswt) compared to treatment with botulinum toxin to improve spasticity in patients with cerebral palsy the number needed of patients is 70 (35 per group). leaving a period of washout between one therapy and the other

outcome measures: the primary outcome will be to measure spasticity with passive range of motion of the foot (prom) by muscular extensibility and its traction reflex using goniometryit will be assessed at baseline before the treatment, as well as after 3 weeks, 2 months, 3 months, after the washout period (3months), 3 months and 3 weeks, 5 months and 6 months, when the end the intervention. secondary outcome includes: 1) pain will be assessed with visual analog scale (vas) after the first application of each therapy. 2) ascertain if the type of gross motor functional classification system (gmfcs) has an influence on the improvement of these two treatments; 3) assess whether infiltration of botulinum toxin in other muscle groups have influence on the results of study; and 4) undergo a qualitative registration to know the perception and experience that patient/family will have during this study, through a satisfaction questionnaire.

Eligibility criteria:
inclusion criteria: * age between 5 and 55 years * any level of gmfcs (gross motor function classification system) * the patient consent to participate in the study * diagnosis of spastic cerebral palsy * triceps surae spasticity in them. * the dynamic foot deformity. * extensibility between 0 ° and 20 ° in dorsal flexion passive way. * do not be diagnosed important cutaneous alterations. exclusion criteria: * associate neuromuscular disease. * surgical intervention to augment the balance articulate and / or reduce the spasticity in the last six months. * fixed foot deformity. * etiology of factors: or genetic bone disorders / disturbances soft parts. position with anomalies or alterations in soft parts or bone alterations (mechanical). * unable to follow the treatment. * allergy to botulinum toxin.

Keywords: shockwaves physiotherapy botulinum toxin
regorafenib in subjects with metastatic colorectal cancer (mcrc) who have progressed after standard therapy

Conditions: Colorectal Neoplasms

Summary: this is an open-label phase iii study of regorafenib in patients with metastatic colorectal cancer (mcrc) who have progressed after all approved standard therapy. the purpose of this study is to provide additional information about the safety profile of regorafenib.


Eligibility criteria:
inclusion criteria: * male or female subjects \>/= 18 years of age * life expectancy of at least 3 months * histological or cytological documentation of adenocarcinoma of the colon or rectum * subjects with metastatic colorectal cancer (stage iv) * progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab if kras wt (wt: wild-type i.e. no kras mutation) * eastern cooperative oncology group (ecog) performance status of \</= 1 * adequate bone marrow, liver and renal function as assessed by the following laboratory requirements * women of childbearing potential and men must agree to use adequate contraception since signing of the inform consent (ic) form until at least 3 months after the last study drug administration exclusion criteria: * prior treatment with regorafenib * major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug * pregnant or breast-feeding subjects * congestive heart failure \>/= new york heart association (nyha) class 2 * myocardial infarction less than 6 months before start of study drug * ongoing infection \> grade 2 common terminology criteria for adverse events (ctcae) v. 4.0 * renal failure requiring hemo-or peritoneal dialysis

Keywords: regorafenib metastatic colorectal cancer
oral moxifloxacin versus cefazolin and oral probenecid in the management of skin and soft tissue infections in the emergency department

Conditions: Cellulitis

Summary: patients often come to the emergency department with bacterial skin infections (known as "cellulitis"). some patients with very severe infections are admitted to hospital for antibiotic treatment and some are sent home on oral antibiotics. many patients have moderate infections and are treated as outpatients with daily intravenous antibiotics for 2-5 days. in this patient group it is unclear if treatment with oral antibiotics is as effective as intravenous antibiotics. the purpose of this study is to determine if treatment of moderate cellulitis with an intravenous antibiotic (cefazolin) for 3-5 days is as effective as treatment with an oral antibiotic (moxifloxacin). we hypothesize that the oral agent will be as effective as intravenous treatment for moderate cellulitis.

extended description of the protocol, including information not already contained in other fields. objective: to compare 400 mg of oral moxifloxacin (oral group) once daily to 2 grams of iv cefazolin and 1 gram of oral probenecid once daily (iv group) for the treatment of moderate cellulitis. patients: any patient presenting to the emergency department at st paul's hospital in vancouver with a diagnosis of cellulitis requiring iv antibiotics, without contraindications to any of the study treatments, and not requiring hospital admission. assessments: daily assessments are performed double-blind at 0, 1, 2, 3, 4, 5, 6, 7 and 14 days. primary outcome: clinical cure at 7 days (resolution of symptoms, no change in antibiotic, no adverse events requiring discontinuation of study drug, no admission to hospital). secondary outcomes: area of erythema, days of treatment, side-effects of medication, cost of treatment, patient satisfaction, relapse at 14 days. sample size: based on equivalence of treatments a total of 390 patients are required (195/group).

Eligibility criteria:
inclusion criteria: * cellulitis requiring outpatient intravenous antibiotic therapy; * ability to understand,/sign informed consent; * no contraindications to study medications, * not pregnant/breastfeeding exclusion criteria: -

Keywords: cellulitis, rct, emergency department, double-blind, equivalence trial, moxifloxacin, cefazolin, probenecid.
multiple ascending dose and ddi study

Conditions: Healthy Volunteers

Summary: part a will investigate the safety, tolerability, pk and pd of pf-06835919 administered for 14 days in a multiple ascending dose design. part b will assess the effect of pf-06835919 co-administration at low and high doses on the pk of atorvastatin in a single cohort.


Eligibility criteria:
inclusion criteria: * healthy male and females (nonchildbearing potential) * 18 to 55 years old * body mass index 17.5 to 30.5 exclusion criteria: * known hereditary fructose intolerance or fructose malabsorption disorder (part a) * statin intolerance (part b) * unable to consume high fructose syrup-containing beverage with each meal while in the unit (part a)

Keywords: nonalcoholic steatohepatitis
comparison of aqueous humor adipokines in glaucoma patients and healthy controls

Conditions: Glaucoma; Adipokines

Summary: the purpose of this study is to observe whether there are differences in adipokines in the aqueous humor between patients with primary open-angle glaucoma (poag) and healthy controls

1. inclusion criteria: patients aged 18 years or older, diagnosed with primary open-angle glaucoma (poag) and healthy controls (who underwent cataract surgery). 2. exclusion criteria: 1. other ocular diseases: patients with concurrent ocular diseases such as macular degeneration, retinal detachment, etc., are excluded. 2. ocular surgery history: individuals who have undergone intraocular or laser surgery within the past 6 months, except for uncomplicated cataract surgery. 3. history of ocular trauma or inflammation 4. systemic diseases or mental disorders: patients with systemic diseases(e.g., diabetes, rheumatoid arthritis) and those with mental disorders are excluded. 5. pregnancy or lactation: females who are pregnant or lactating are excluded. 6. presence of any retinal or optic nerve disease other than glaucoma.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older, diagnosed with primary open-angle glaucoma (poag) and healthy controls (who underwent cataract surgery). exclusion criteria: * other ocular diseases: patients with concurrent ocular diseases such as macular degeneration, retinal detachment, etc., are excluded. * ocular surgery history: individuals who have undergone intraocular or laser surgery within the past 6 months, except for uncomplicated cataract surgery. * history of ocular trauma or inflammation * systemic diseases or mental disorders: patients with systemic diseases(e.g., diabetes, rheumatoid arthritis) and those with mental disorders are excluded. * pregnancy or lactation: females who are pregnant or lactating are excluded. * presence of any retinal or optic nerve disease other than glaucoma.

Keywords: glaucoma；adipokines；neuroinflammation
different doses of vpdt in the treatment of ccsc

Conditions: Central Serous Chorioretinopathy; Therapy, Photodynamic

Summary: this is a prospective, randomized and controlled clinical trial of photodynamic therapy (pdt) for chronic central serous chorioretinopathy (csc). the patients who met the inclusion criteria were randomly divided into 50% dose pdt treatment group and 70% dose pdt treatment group. the primary treatment success rate and adverse event rate of the two groups were compared by optical coherence tomography (oct), and then the best pdt treatment scheme for chronic csc was summarized.


Eligibility criteria:
inclusion criteria: * 18-75 years old, regardless of gender; * meet the diagnostic criteria of central serous chorioretinopathy; * the course of csc (subject to the symptoms of this disease) is more than 3 months; * patients with simultaneous diseases of both eyes were included in those with more subretinal fluid. exclusion criteria: * macular neuroretinal detachment caused by rhegmatogenous retinal detachment, uveitis, age-related macular degeneration, polypoid choroidal angiopathy and other fundus diseases; * a previous history of pdt treatment; * systemic hormone or local hormone nasal spray is being used, or hormone is stopped for less than 3 months.
procedural efficiency and organisational impact of rhino laryngoscopes procedures in consults

Conditions: Laryngeal Disease

Summary: the aim of this study is to investigate the procedure efficiency, organisational and economic impact, and physician evaluation of the conventional reusable rhino laryngoscope vs. ambu® ascope™ 4 rhinolaryngo in procedures conducted distally form the ent department e.g. in the emergency department (ed), intensive care unit (icu), ward etc., i.e. consults.

the aim of this study is to investigate the procedure efficiency, organisational and economic impact, and physician evaluation of the conventional reusable rhinolaryngoscope vs. ambu® ascope™ 4 rhinolaryngo in procedures conducted distally from the ent department e.g. in the emergency department, intensive care unit, ward etc., i.e. consults. the study will be prospective and randomised until 13 procedures have been performed in each group followed by an assessment of the organisational impact and cost comparison of the two technologies. the investigator will track the time and evaluate the device after each procedure. the organisational impact will be accessed by a questionnaire following the study period. a cost comparison will be enabled via tracking all the processes associated with the rhinolaryngoscopes. after tracking all equipment, time, and utilities will be ascribed a cost.

Eligibility criteria:
inclusion criteria: * the investigator has been trained and conducted at least 5 successful training procedures with both the ascope 4 rhinolaryngo and the reusable rhinolaryngoscope systems. * the investigator on call for consults must be available to fill out the crf immediately before and after the procedure. * the investigator must be dedicated to the study while on call for consults * clinical indication and eligible for a rhino laryngoscopy, as judged by the physician * patients ≥18 years exclusion criteria: * if the patient has no clear indication for rhino laryngoscopy the procedure should not be conducted.
long-term follow-up study of patients receiving car-t cells

Conditions: Chronic Lymphocytic Leukemia; Lymphomas Non-Hodgkin's B-Cell; Lymphoma, Small Lymphocytic; Mantle Cell Lymphoma; Central Nervous System Lymphoma; Diffuse Large B Cell Lymphoma; Follicular Lymphoma; Burkitt Lymphoma; Multiple Myeloma

Summary: this protocol is designed as a long-term follow-up study of participants who will receive car-t cells as part of a clinical trial at the medical college of wisconsin/ froedtert hospital. the clinical trials include the following: phase 1 study of car-20/19-t cells in patients with relapsed refractory b cell malignancies (nct03019055); phase i trial of bcma-tgf-beta car-t cells in relapsed, refractory myeloma (nct05976555); car20.19.22 t-cells in relapsed, refractory b-cell malignancies (nct05094206); lv20.19 car t-cells in combination with pirtobrutinib for relapsed, refractory b-cell malignancies (nct05990465); car-20/19-t cells in patients with relapsed refractory b cell malignancies (nct04186520)

the objective is to follow participants receiving car-t cells from years 2 to 15 post-treatment for persistence of car-t cells, development of secondary malignancies, or other medical complications.

Eligibility criteria:
inclusion criteria: * all participants who enrolled in a car-t study at froedtert hospital \& the medical college of wisconsin. exclusion criteria: * there are no exclusion criteria for this study.

Keywords: car-t cell therapy chimeric antigen receptor
3d printed made to measure splints for hand patients

Conditions: Splints

Summary: this study aims to evaluate the feasibility and possible benefits of 3d-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients (intervention group) in comparison to thermoplastic splints individually adjusted by occupational therapists (control group).


Eligibility criteria:
inclusion criteria: * patients presenting to the hand surgical department of the university hospital basel * patients with hand trauma w/wo the need for hand surgery or patient with planned elective hand surgical intervention * indication for immobilization of at least 4 weeks * older than 18 years * capable of consent * informed consent as documented by signature exclusion criteria: * open wounds with tissue loss * injury with the need for external fixation * younger than 18 years * not capable of consent * asymmetric deformity or loss of the contra-lateral hand * documented hypersensitivity or allergy to polylactic acid * known or suspected non-compliance to agreed treatment measures and/or unexcused nonappearance to hospital appointments * drug or alcohol abuse * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * previous enrolment into the current study

Keywords: hand trauma splint made to measure 3d print
diaphragmatic thickness and functional exercise capacity in lobectomy surgeries with thoracotomy and vats

Conditions: Video Assisted Thoracoscopic Surgery; Thoracic Surgery; Respiratory Muscles

Summary: the most commonly treatment for early stage non-small cell lung cancer (nsclc) is lobectomy. different surgical interventions during lobectomy are thought to have different effects on respiratory functions and exercise capacities. the aim of this study was to evaluate respiratory muscle strength, functional exercise capacity, and diaphragmatic thickness in groups that underwent lobectomy with standard thoracotomy, muscle sparing thoracotomy, and video-assisted thoracic surgery (vats).

the most commonly treatment for early stage non-small cell lung cancer (nsclc) is lobectomy. different surgical interventions during lobectomy are thought to have different effects on respiratory functions and exercise capacities. the aim of this study was to evaluate respiratory muscle strength, functional exercise capacity, and diaphragmatic thickness in groups that underwent lobectomy with standard thoracotomy, muscle sparing thoracotomy, and video-assisted thoracic surgery (vats). in this study we will evaluate respiratory muscle strength, functional exercise capacity, diaphragmatic thickness, postoperative pulmonary complications, pain, dyspnea, pulmonary function, functional status, anxiety and depression.

Eligibility criteria:
inclusion criteria: * being a lung cancer patient scheduled for standard thoracotomy, muscle sparing thoracotomy, or lobectomy with vats, * being clinically stable, * volunteering to participate in the study, * be between the ages of 18-75, * to be cooperative in the tests to be done. exclusion criteria: * having an orthopedic and neurological condition that prevents walking, - having undergone any surgery on the thoracic wall, * diagnosed with small cell lung cancer.

Keywords: lung cancer, functional capacity
study of gemcitabine/carboplatin/bevacizumab to treat ovarian, fallopian tube or primary peritoneal cancer

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Summary: the purpose of this study is to test the effectiveness, safety and tolerability of the drug combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal cancer.

in this study participants will receive the drug combination gemcitabine/carboplatin and bevacizumab once every two weeks. as long as there is evidence that the tumor is not growing and the participant is not experiencing any unacceptable side effects, participation can continue up to 2 years. the study is being done to find the effectiveness, safety and tolerability of this combination of chemotherapy drugs. bevacizumab affects the growth of new blood vessels in the body. it is part of this study to see if stopping the growth of new blood vessels in the body will help stop the growth and the spread of cancer. the other two chemotherapy drugs, gemcitabine and carboplatin, are currently being used together for the treatment of ovarian cancer.

Eligibility criteria:
inclusion criteria: * cancer of the ovaries, fallopian tube or abdominal lining has come back after more than 6 months from the last platinum based chemotherapy treatment. * disease must be detected by ct or ca125 level must be elevated or cancerous ascites must be present. * history of at least one therapy of platinum based chemotherapy. exclusion criteria: * participation in another experimental drug study * heart disease or high blood pressure * history of a stroke within the past 6 months * vascular disease, or bleeding problems * brain cancer * major surgical procedure within 28 days prior to start date * minor surgical procedures within 7 days prior to start date * pregnant or lactating * abdominal or bowel problems like bleeding * history of abdominal fistula, gi perforation or intra-abdominal abscess * serious, non-healing wound, ulcer or bone fracture * acute hepatitis * active infections requiring antibiotics * inability to comply with study or follow up procedures

Keywords: ovarian cancer platinum sensitive cancer fallopian tube cancer peritoneal cancer
implementing technology enhanced real time action observation therapy in persons with chronic stroke

Conditions: Chronic Stroke; Hemiplegia; Hemiparesis; Paralysis

Summary: this is a feasibility study to alter the microsoft kinect software to be used as a rehabilitation tool. the prototype used is still in the early developing stage. the purpose of this research study is to develop a prototype of altered microsoft kinect software and determine its use in improving the function of the study subjects' weaker extremities. the altered software will allow a viewing of the mirror image of the involved limb as it is moved. however, the image that is viewed will reflect normal movement even if the limb cannot move normally. by viewing normal movement of the weaker limbs the "mirror neuron" network in the brain will become activated and will ultimately improve the function of the weaker side.


Eligibility criteria:
inclusion criteria: * - adults 40 years of age and older having had a stroke greater than 6-months post onset * able to follow commands in english * medically stable and without acute illness, such as infection, inflammation, ongoing chest pain, or short of breath with walking and light activities * able to stand up off of a standard height chair (16-18 inches) exclusion criteria: * - cognitive impairment as measured by a score below 24/30 on mini mental state examination * a diagnoses of cancer involving the nervous or musculoskeletal system * severe pain in arms, legs, or spine measured by \>6/10 using verbal numerical pain rating scale that prevents them from standing or walking independently * diagnoses of other neurological diseases except for stroke, such as spinal cord injury or parkinson's disease etc. * individuals at the advanced stage of a disease and with less than 12 months to live.

Keywords: kinect rehabilitation virtual reality mirror therapy